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Determination of metabolite of nicergoline in human plasma by high-performance liquid chromatography and its application in pharmacokinetic studies 被引量:3
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作者 Rong Zheng, Yi-Hong Wu, De-Xi Jiang, Dan Zhang West China School of Pharmacy, Sichuan University, Chengdu 610041, China 《Journal of Pharmaceutical Analysis》 SCIE CAS 2012年第1期62-66,共5页
A fast, simple and sensitive high performance liquid chromatographic (HPLC) method has been developed for determination of 10a-methoxy-6-methyl ergoline-8b-methanol (MDL, a main metabolite of nicergoline) in human pla... A fast, simple and sensitive high performance liquid chromatographic (HPLC) method has been developed for determination of 10a-methoxy-6-methyl ergoline-8b-methanol (MDL, a main metabolite of nicergoline) in human plasma. One-step liquid–liquid extraction (LLE) with diethyl ether was employed as the sample preparation method. Tizanidine hydrochloride was selected as the internal standard (IS). Analysis was carried out on a Diamonsil ODS column (150 mm 4.6 mm, 5 mm) using acetonitrile–ammonium acetate (0.1 mol/L) (15/85, v/v) as mobile phase at detection wavelength of 224 nm. The calibration curves were linear over the range of 2.288–73.2 ng/mL with a lower limit of quantitation (LLOQ) of 2.288 ng/mL. The intra-and inter-day precision values were below 13% and the recoveries were from 74.47% to 83.20% at three quality control levels. The method herein described was successfully applied in a randomized crossover bioequivalence study of two different nicergoline preparations after administration of 30 mg in 20 healthy volunteers. 展开更多
关键词 Nicergoline 10a-methoxy-6-methy- lergoline-8b-methanol (MDL) HPLC Plasma-drug concentration Bioequivalence study
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